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Class 2 Device Recall Guidant VITALITY AVT |
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Date Initiated by Firm |
May 15, 2006 |
Date Posted |
July 27, 2006 |
Recall Status1 |
Terminated 3 on March 02, 2008 |
Recall Number |
Z-1291-06 |
Recall Event ID |
35525 |
PMA Number |
P960040/S29 P960040S035 |
Product Classification |
Implantable Cardioverter Defibrillator - Product Code LWP
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Product |
VITALITY AVT, model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. |
Code Information |
model A155, serial numbers: 113567, 113568, 113569, 113570, 113572, 113574, 113585, 113586, 113587, 113591, 113612, 113613, 113616, 113617, 113618, 113619, 113620, 113621, 113623, 113624, 113626, 113627, 113628, 113629, 113631, 113633, 113635, 113637, 113639, 113640, 113641, 113654, 113659, 113660, 113672, 113674, 113675, 113676, 113678, 113679, 113680, 113681, 113682, 113684, 113686, 113687, 113690, 113693, 113694, 113695, 113696, 113778, 113779, 113781, 113783, 113784, 113789, 113791, 113792, 113814, 113908, 113910, 113912, 113913, 113914, 114083 |
Recalling Firm/ Manufacturer |
Boston Scientific CRM Corp 4100 Hamline Ave N Saint Paul MN 55112-5700
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For Additional Information Contact |
Guidant 866-484-3268
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Manufacturer Reason for Recall |
Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. If function of this low voltage capacitor is compromised, the battery may deplete prematurely.
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FDA Determined Cause 2 |
Other |
Action |
An Urgent Medical Device Safety Information & Corrective Action letter, dated May 12, 2006, was sent to physicians. The letter gave a description of the issue, clinical implications, rate of occurrence, devices affected and recommendation. Physicians are asked to follow-up with affected patients as soon as possible because ERI to EOL time may be shortened. Physicians are asked to contact Guidant for instructions on performing a baseline 'save to disk' and provide this information to Guidant. Guidant will be able to analyze the device memory data and estimate remaining longevity and provide individualized follow-up and replacement guidelines. Subsequent follow-up visits should continue to monitor for evidence of premature battery depletion. |
Quantity in Commerce |
66 |
Distribution |
Nationwide including Puerto Rico. Worldwide, including Argentina, Belgium, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Portugal, Spain, Syrian Arab Republic, United Arab Emirates |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database |
PMAs with Product Code = LWP and Original Applicant = BOSTON SCIENTIFIC
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